Clinical trial

Clinical Evaluation of the Long-term Benefit of Enteric-coated Mycophenolate (MPAs) After Liver Transplantation

Name
[2022]02-146-01
Description
MPA drugs are antiproliferative immunosuppressants and are widely used in solid organ transplantation. MPA drugs do not affect the recipient's kidney function and do not cause metabolic abnormalities and other problems. Intestinal solvent-based MPA drugs are widely used in clinical practice by improving the dosage form, reducing the irritation of MPA to the mucosa of the digestive tract, improving the tolerability of patients and maintaining a sufficient amount of MPA. However, data on the use/long-term use of intestinal solvent-based MPAs in liver transplant recipients are lacking. The study aims to evaluate the long-term benefits of enteric-coated mycophenolic acid in liver transplant recipients.
Trial arms
Trial start
2022-12-04
Estimated PCD
2023-06-30
Trial end
2023-09-30
Status
Recruiting
Treatment
enteric-coated mycophenolate (MPAs)
Immunosuppression protocol with enteric-coated mycophenolate sodium
Arms:
MPA
None MPA
Immunosuppression protocol without enteric-coated mycophenolate sodium
Arms:
None MPA
Size
500
Primary endpoint
complex endpoint
60 months after liver transplantation
Eligibility criteria
Inclusion Criteria: * Patients who underwent their first liver transplantation between January 1, 2016 and February 28, 2021; * Recipient's survival time≥ 1 year; * Age 18\~65 years old; * Patients with complete data and no loss to follow-up. Exclusion Criteria: * use of other types of anti-metabolic immunosuppressants; * Second liver transplantation for various reasons within 1 year after the first transplantation; * Patients with serious underlying diseases, including heart disease, infection and renal insufficiency, combined with other malignant tumors.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 500, 'type': 'ESTIMATED'}}
Updated at
2023-02-01

1 organization

2 products

2 indications

Product
MPA